BEUDAMED
    FDA Recall Terminated

    LifePort, Dual Lumen Profile Plastic Dual Port with Poly Urethane Catheter Kit, Product Code/REF: LPS 7255, Manufactured by: Horizon Medical Products, Inc., One Horizon Way, P.O. Box 627, Manchester, GA 31816.The devices are placed in a molded PVC tray. The tray is sealed with a Tyvek lid. The inner sealed tray is then placed in another tray, the Instruments for Use (IFU), Patient Information Booklet (PIB), patient ID card and its label, the IFU for the locking mechanism and the labeling describing the materials and priming volume, are all placed on top of that lid before sealing the outer tray with another Tyvek lid. The product label is applied to the outer tray lid and the entire package-tray inside a tray is then sterilized. The primary sterile barrier is the inner sealed tray.

    Recall: Z-0256-05 · Initiated September 20, 2004

    Recall

    Recall Number
    Z-0256-05
    Event Number
    30048
    Firm
    Horizon Medical Products Inc
    FEI Number
    3017892510
    Product Code
    LJT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 20, 2004
    Posted
    November 24, 2004
    Terminated
    March 1, 2005
    Address
    1 Horizon Way, Manchester, GA, 31816-1749

    Description

    LifePort, Dual Lumen Profile Plastic Dual Port with Poly Urethane Catheter Kit, Product Code/REF: LPS 7255, Manufactured by: Horizon Medical Products, Inc., One Horizon Way, P.O. Box 627, Manchester, GA 31816.The devices are placed in a molded PVC tray. The tray is sealed with a Tyvek lid. The inner sealed tray is then placed in another tray, the Instruments for Use (IFU), Patient Information Booklet (PIB), patient ID card and its label, the IFU for the locking mechanism and the labeling describing the materials and priming volume, are all placed on top of that lid before sealing the outer tray with another Tyvek lid. The product label is applied to the outer tray lid and the entire package-tray inside a tray is then sterilized. The primary sterile barrier is the inner sealed tray.

    Reason

    The product has an incorrectly sized introducer included in the kit. The kit contains a 12 French introducer instead of a 7 French introducer.

    Action

    Consignees were notified by letter on 09/20/2004.

    Distribution

    FL, GA, LA, MD, NJ, OK, TX, VA

    Quantity

    44 kits